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Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490776
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the safety and efficacy of LBH589B in adult patients with refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma Drug: LBH589 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor
Study Start Date : June 2007
Actual Primary Completion Date : September 2009

Arm Intervention/treatment
Experimental: LBH589 Drug: LBH589
Other Name: panobinostat

Primary Outcome Measures :
  1. To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ]
  2. To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ]
  3. Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ]
  4. Overall response rate of patients with resistant CTCL treated with oral LBH589 by using the modified Physician's Global Assessment (PGA) to assess skin disease and the evaluation of disease in the viscera, lymph nodes and blood (circulating SS cells). [ Time Frame: Monthly ]
  5. Duration of response [ Time Frame: Monthly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Written informed consent obtained prior to any screening procedures
  2. Age greater than or equal to 18 years old
  3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible. Patients with transformed CTCL are eligible.
  4. Patients must have been treated with an HDAC inhibitor given for the treatment of CTCL. Patients must have had disease progression on or following treatment with an HDAC inhibitor. Patients are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Patients previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.

Exclusion criteria:

  1. Patients with a history of visceral disease including CNS involvement (i.e. stage IVB CTCL). Note, patients who have SS with bone marrow involvement are eligible.
  2. Impaired cardiac function
  3. Concomitant use of drugs with a risk of causing torsades de pointes
  4. Patients who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  5. Less than 3 months since prior electron beam therapy
  6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490776

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United States, Alabama
University of Alabama at Birmingham/ The Kirklin Clinic
Birmingham, Alabama, United States, 35233
United States, California
UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Health Sciences Center/Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80010
United States, Florida
Florida Academic Dermatology Centers
Miami, Florida, United States, 33136
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Rush Presbyterian Hospital/St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Missouri
St. Louis University Cancer Cennter
St. Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Our Lady of Mercy Medical Center/Comprehensive Cancer Center
Bronx, New York, United States, 10466
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
NYU Clinical Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Wake University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
University of Oklahoma-Tulsa
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Craig Okada
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburg Medical Center
Pittsburg, Pennsylvania, United States, 15213
United States, Tennessee
The Jones Clinic
Germantown, Tennessee, United States, 38138
United States, Texas
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-102
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00490776     History of Changes
Other Study ID Numbers: CLBH589B2212
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cutaneous T-Cell Lymphoma
Mycosis Fungoides
Sézary Syndrome

Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action